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Bupropion hydrobromide - Generic Drug Details

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What are the generic sources for bupropion hydrobromide and what is the scope of freedom to operate?

Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrobromide has fifty-three patent family members in eighteen countries.

There are thirty-eight drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for bupropion hydrobromide

International Patents:	53
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	38
Suppliers / Packagers:	1
Bulk Api Vendors:	15
Clinical Trials:	3
Patent Applications:	72
Formulation / Manufacturing:	see details
DailyMed Link:	bupropion hydrobromide at DailyMed

Recent Clinical Trials for bupropion hydrobromide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Medical University of South Carolina	Phase 1
Valeant Pharmaceuticals International, Inc.	Phase 4

See all bupropion hydrobromide clinical trials

Generic filers with tentative approvals for BUPROPION HYDROBROMIDE

Applicant	Application No.	Strength	Dosage Form
		522MG	TABLET, EXTENDED RELEASE; ORAL
		174MG	TABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bupropion hydrobromide

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Paragraph IV (Patent) Challenges for BUPROPION HYDROBROMIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
APLENZIN	TABLET, EXTENDED RELEASE;ORAL	bupropion hydrobromide	022108	2009-12-24
APLENZIN	TABLET, EXTENDED RELEASE;ORAL	bupropion hydrobromide	022108	2009-09-28
APLENZIN	TABLET, EXTENDED RELEASE;ORAL	bupropion hydrobromide	022108	2009-09-24

US Patents and Regulatory Information for bupropion hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y

International Patents for bupropion hydrobromide

Country	Patent Number	Estimated Expiration
Russian Federation	2007147343
China	101784266
World Intellectual Property Organization (WIPO)	2008001341

Supplementary Protection Certificates for bupropion hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	122017000109	Germany		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330